It is thus appropriate to modify as follows the existing Requirements for. Rabies Vaccine for Human Use. General considerations (page 58). Replace the. Three rabies vaccines for human use derived from different rabies virus strains Animals; Biological Assay/methods*; Biological Assay/standards; Biological. BIOLOGICAL ASSAY OF RABIES ANTISERUM: The potency of rabies antiserum is determined by comparing a lethal intracerebral dose of.
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Automatically changes to Flash or non-Flash embed. WordPress Embed Customize Embed. Presentation Description No description available. Dephtheria anti-toxin is preparation containing antitoxic globulins that they have the power of specifically neutralizing the toxin formed by Cornebacterium diphtheria.
It is obtained by fractionation from the serum of horses or other mammals that have been immunized against diphtheria toxin. The potency of diphtheria anti-toxin is determined by comparing the dose necessary to protect guinea-pig or rabbits against the erythrogenic effect of a fixed dose of the standard preparation of diphtheria anti toxin necessary to give the same protection.
The toxin should be selected for assay. Saline solution prepared having the 1ml biassay 0. Stay min protected from the light. Observe the animals bipassay 48hrs Mixture containing larger amount of toxin gives the larger reaction Mixture containing less amount of toxin gives the smaller reaction Slide 6: Test bioaszay and std dose contains 0. Protected from the light.
The no of units per ml Either it is from horse of other mammals Recommended dose preservatives Slide 9: Rabies vaccine is a suspension of a suitable strain of fixed rabies grown in suitable approved cell culture and inactivated by gioassay suitable method.
The vaccine is prepared immediately before use by reconstitution from the dried vaccine with a suitable sterile liquid. The potency of rabies vaccine is determined by comparing a lethal intracerebral dose of a rabies arbies with the dose of the standard preparation of rabies vaccines necessary to give for same protection.
Freeze — dried preparation. Potency is determined by international reference Slide White mice weight 11gg. These two groups are used for titration of Vioassay of challenge suspension. The potency of rabies antiserum is determined by comparing a lethal intracerebral dose of rabies virus with the dose of standard preparation of rabies antiserum necessary to give same protection.
Standard preparation is dried serum or Other preparationthe potency of which has been determined in relation to international standard. Mice, 10gg -animal same sex. Any suitable strain rabies virus of known potency, such as the CVS strain may be used.
Tetanus anti-toxin is a preparation containing antitoxic globulins that have the power of specifically neutralizing the toxin formed by clostridium tetani. It is obtained by fractionation from horse serum or other mammals that have been immunized against tetanus toxin. The potency of tetanus anti-toxin is determined bioaassay comparing the dose necessary to protect the mice against the paralytic effects.
Standard preparation containing freeze dried hyper immune horse serum. Prepare standard preparation with saline solution final concentration Prepare mixture of solution: LP means limes paralyticum This is the smallest quantity tabies the toxin when nioassay with 0. Neomycin sulphate is a mixture of compounds obtained by the growth certain strains of streptomyces fradie. Peptone 6gm Pancreatic digest of casein 4gm Yeast extract 3gm Beaf extract 1.
Suggested inoculums bioassa amount – 0. The prepared plates or dishes must be stored such that no significant growth of the test microorganism occurs before use, and the surface of the agar layer is dry at the time of use. Solution of known concentration of the std. The volume of solution added to each cylinder or cavity must be uniform and sufficient to fill the holes. Then they are incubated or about 24 hours at about and the diameter or areas of the circular inhibition zones are measured.
It is a neurosecretary product mainly synthesize in the cell bodies of paraventracular nuclear of the hypothalamus. Oxytocin stimulate the contraction of the uterine smooth muscle and the memory gland. Oestrogen progesterone and prolactin — responsible for production of milk by memory gland but milk ejection require oxytocin.
Oxytocin facilitates the contraction of uterus. Oxytocin may be presented as a solid or as a solution in a solvent containing an appropriate antimicrobial preservative such as 0. If it is derived from animal species. The potency of oxytocin is determined by comparing its activity with that of the standard preparation of oxytocin of under the conditions of a suitable method of assay.
Consisting free dried synthetic oxytocin peptide ranies human albumin citric acid Slide P Exposure the gluteus primus muscle thigh and remove politeal artery and crural vein. Cannulate the popliteal artery is record the B. P response Cannulate the crural or brachial vein. Prepare standard solution with saline solution. P response Dose should cause decrease in B.
Internal between two injection between minutes depending on the rate at which B.
P return to normal Dilute the preparation with saline solution so as to get same response as standard The ratio between standard and test should be equal If the animal rapidly becomes insensitive to the repeated injection the solution another must be used. Measure all the responses are calculated the result of the assay by std statistical method. By contraction of the rat uterus: Inject mcg of oestradiol benzoate intramuscularly into female rat before the assay Immediately before the assay confirm by vaginal…….
Record the contraction produces by the addition of two dose of std.
PHARMACOLOGY: Biological Assay of Diphtheria Antitoxin
Dose should be added at regular interval[minutes] Slide Similarly record the contraction of test preparation as standard. Ratio between two dose of test and two dose of standard should be equal This ratio kept constant through out the assay. Measure all the response and calculate the result of the assay by standard statistical method. Standard cyancoblamine stock solution diluted with water[0. HCl [to PH 6.
Dissolve in following order L-cystine DL-trptophan dissolved in 1N — HCL and then Adenine-guanine uracil if Xanthene solution Riboflavin — thiamine-biotin — nicotine acid solution P-amino benzoic rabiew — pyridoxine-pyridoxal- pyridoxamine solution.
Salt solution — A. Acid digested casein solution.
Dilute 25ml of basal medium stock solution with equal volume of H2O sterile in autoclave. Transfer few cells of lacto bacillus leichmanii from a subculture onto 2 sterile tubes with 10ml culture medium. Incubation at c for hrs. Centrifuge decant supernatant liquid.
Suspended cells in 10ml of sterile suspension medium. Centrifuge decant of supernatant liquid og 3 times]. Suspend the cells in 10ml of sterile suspension medium 1ml of the suspension vacciine cells 10ml sterile suspension mix the inoculums Slide Standard preparation Test preparation To triplicate test tubes 0ml 0. Nor inoculums is added incubate at hcs. On a graph paper, plot the transmittance value against the corresponding levels of std.
Discard any values falling beyond the range. Calculate the potency from the average of these remaining values.
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Upload from Desktop Single File Upload. The presentation is successfully added In Your Favorites. Observe the animals after 48hrs Mixture containing larger amount of toxin gives the larger reaction Mixture containing less amount of toxin gives the smaller reaction. The no of units per ml Either it is from horse of other mammals Recommended dose preservatives. Potency is determined by international reference.
Consisting free dried synthetic oxytocin peptide with human albumin citric acid. Dose should be added at regular interval[minutes]. Suspend the cells in 10ml of sterile suspension medium 1ml of the suspension of cells 10ml sterile suspension mix the inoculums.
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